MAUDE Adverse Event Report: MAKO SURGICAL RESTORIS MULTICOMPARTMENTAL KNEE PROSTHESIS

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Arthralgia (2355)

Event Date 05/01/2014

Event Type  Injury  

Event Description

The patient had received bilateral partial knee arthroplasty procedures using the robotic arm interactive orthopedic system (rio) and restoris multicompartmental knee (mck) implants.The patient contacted mako surgical inquiring about the material composition of the mck implants.In (b)(6) 2014, almost a year following the original procedure, the patient began experiencing a skin rash near the base of the skull, which then spread to the patient's legs and back.The patient has sought medical attention, and several antihistamines have failed to relieve her symptoms.

Manufacturer Narrative

As part of normal complaint follow-up, an evaluation of the event has been initiated at mako surgical.Due to the long period of time between the patient's procedure and the appearance of the rash, it is not believed that the mck implants nor the mako plasty procedure contributed to the patient's condition.A response will be provided to the patient with the material composition of the implants, as well as a recommendation to consult with a makoplasty physician.The investigation is currently ongoing, and a supplemental report will be filed when additional information is obtained.

• Brand Name: RESTORIS MULTICOMPARTMENTAL KNEE PROSTHESIS
• Type of Device: COMPARTMENTAL KNEE PROSTHESIS
• Manufacturer (Section D): MAKO SURGICAL; ft. lauderdale FL
• Manufacturer Contact: william tapia ; 2555 davie rd.; ft. lauderdale, FL 33317 ; 9546280605
• MDR Report Key: 4044759
• MDR Text Key: 4866142
• Report Number: 3005985723-2014-00105
• Device Sequence Number: 1
• Product Code: NPJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090763
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/21/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO)
• Patient Outcome(s): Other